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. 2015 Jun 8;10(6):e0129289. doi: 10.1371/journal.pone.0129289

Table 4. Adjusted mean change from baseline to week 24 in SF-36 dimensions in patients with a high drinking risk level (MMRM, target efficacy population).

Short-Form health survey-36 (SF -36) Dimensions Baseline Change from Baseline to Week12 Difference to Placebo Change from Baseline to Week 24 Difference to Placebo
N Mean ± SD N Mean ± SE Mean ± SE 95% CI p-value N Mean ± SE Mean ± SE 95% CI p-value
Bodily Pain Placebo 319 49.16 ± 10.66 279 0.73 ± 0.67 226 1.47 ± 0.70
Nalmefene 316 49.85 ± 10.63 283 2.46 ± 0.66 1.73 ± 0.74 [0.28; 3.17] 0.0195 189 3.90 ± 0.72 2.43 ± 0.82 [0.82; 4.05] 0.0032
General Health Placebo 318 43.84 ± 9.56 277 0.85 ± 0.56 224 1.46 ± 0.61
Nalmefene 318 44.71 ± 9.53 283 2.47 ± 0.54 1.62 ± 0.60 [0.45; 2.79] 0.0066 189 3.82 ± 0.62 2.36 ± 0.71 [0.96; 3.76] 0.0010
Mental Health Placebo 319 41.97 ± 11.35 280 2.01 ± 0.66 226 1.82 ± 0.70
Nalmefene 316 41.66 ± 11.34 283 2.01 ± 0.66 1.61 ± 0.71 [0.21; 3.01] 0.0247 188 4.99 ± 0.72 3.17 ± 0.83 [1.54; 4.79] 0.0001
Physical Functioning Placebo 317 50.95 ± 6.84 277 0.50 ± 0.43 223 1.03 ± 0.43
Nalmefene 318 51.01 ± 7.01 281 1.59 ± 0.42 1.09 ± 0.47 [0.16; 2.02] 0.0216 187 2.24 ± 0.44 1.21 ± 0.49 [0.24; 2.18] 0.0142
Role Emotional Placebo 316 42.36 ± 11.40 274 0.67 ± 0.71 221 2.33 ± 0.75
Nalmefene 317 42.46 ± 11.46 280 3.25 ± 0.69 2.58 ± 0.77 [1.06; 4.10] 0.0009 188 4.66 ± 0.77 2.33 ± 0.89 [0.58; 4.08] 0.0093
Role Physical Placebo 316 45.51 ± 9.2 273 0.94 ± 0.56 222 2.00 ± 0.60
Nalmefene 317 45.89 ± 9.34 281 2.64 ± 0.54 1.71 ± 0.60 [0.52; 2.89] 0.0048 188 3.36 ± 0.61 1.36 ± 0.71 [-0.04; 2.75] 0.0561
Social Functioning Placebo 319 43.33 ± 11.95 280 3.93 ± 0.61 226 3.20 ± 0.67
Nalmefene 317 44.32 ± 10.62 284 2.09 ± 0.63 1.84 ± 0.69 [0.49; 3.19] 0.0078 189 5.36 ± 0.68 2.17 ± 0.79 [0.62; 3.71] 0.0061
Vitality Placebo 319 47.04 ± 10.16 280 1.96 ± 0.60 226 1.97 ± 0.65
Nalmefene 319 47.48 ± 9.56 283 3.55 ± 0.58 1.59 ± 0.64 [0.33; 2.86] 0.0135 188 4.30 ± 0.66 2.34 ± 0.77 [0.83; 3.84] 0.0024

MMRM: mixed model repeated measures.